RECRUITING

Echography Study_Anthropometric Measurements

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force. In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force. Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed.

Official Title

Measurement of Skin-to-Muscle and Skin-to-Bone Distances in Adult and Pediatric Populations Before and While Applying a Force Similar to the ZENEO® Triggering Force

Quick Facts

Study Start:2024-02-13

Study Completion:2024-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06279689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, 2 to 70 years old, inclusive 2. In stable health, as determined by medical history and physical examination at screening (ie, any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during assessments, so that in the opinion of the investigator or designee there will not be any impact on the ability of the subject to participate in the study) 3. For the adult population, body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m2 at screening BMI = weight (kg)/(height \[m\])2 4. Willing and able to provide written informed consent and assent (as appropriate) prior to initiation of study procedures 5. Subjects must be able to communicate effectively with the study staff and to understand study instructions (not applicable for toddlers and preschoolers)	1. Any skin or muscular condition, such as eczema, scars, infections, moles, or tattoos at the site of measurements 2. Allergy to ultrasound gel 3. Any other condition or prior therapy that, in the investigator or designee's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures 4. Is an employee or authorized representative of CROSSJECT SA or ICON plc 5. Adult under guardianship or subject incarcerated

Inclusion Criteria

Exclusion Criteria

1. Male or female, 2 to 70 years old, inclusive
2. In stable health, as determined by medical history and physical examination at screening (ie, any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during assessments, so that in the opinion of the investigator or designee there will not be any impact on the ability of the subject to participate in the study)
3. For the adult population, body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m2 at screening BMI = weight (kg)/(height \[m\])2
4. Willing and able to provide written informed consent and assent (as appropriate) prior to initiation of study procedures
5. Subjects must be able to communicate effectively with the study staff and to understand study instructions (not applicable for toddlers and preschoolers)

1. Any skin or muscular condition, such as eczema, scars, infections, moles, or tattoos at the site of measurements
2. Allergy to ultrasound gel
3. Any other condition or prior therapy that, in the investigator or designee's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
4. Is an employee or authorized representative of CROSSJECT SA or ICON plc
5. Adult under guardianship or subject incarcerated

Contacts and Locations

Study Contact

Olivier LACOMBE

CONTACT

+33617685235

o.lacombe@crossject.com

Nathalie Loughraieb

CONTACT

+33380549850

n.loughraieb@crossject.com

Principal Investigator

Nathalie LOUGHRAIEB

STUDY_DIRECTOR

Crossject

Study Locations (Sites)

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Crossject

Nathalie LOUGHRAIEB, STUDY_DIRECTOR, Crossject

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13

Study Completion Date2024-09

Study Record Updates

Study Start Date2024-02-13

Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

Healthy Subjects